TABLE 3.
Summary of Treatment-Emergent Adverse Events (Safety Analysis Set).
| Participants With AE | RE104 5 mg (N=6) n (%) E | RE104 10 mg (N=6) n (%) E | RE104 20 mg (N=6) n (%) E | RE104 30 mg (N=9) n (%) E | RE104 35 mg (N=6) n (%) E | RE104 40 mg (N=3) n (%) E | Pooled Placebo (N=12) n (%) E |
|---|---|---|---|---|---|---|---|
| ≥1 TEAE | 2 (33.3) 3 | 2 (33.3) 4 | 2 (33.3) 5 | 8 (88.9) 30 | 5 (83.3) 31 | 3 (100) 16 | 4 (33.3) 5 |
| Nausea | 1 (16.7) 1 | 2 (33.3) 2 | 0 | 3 (33.3) 3 | 2 (33.3) 2 | 2 (66.7) 2 | 0 |
| Sinus tachycardia | 0 | 0 | 0 | 4 (44.4) 8 | 3 (50.0) 7 | 2 (66.7) 4 | 0 |
| Restlessness | 0 | 0 | 0 | 3 (33.3) 3 | 3 (50.0) 3 | 1 (33.3) 1 | 0 |
| Headache | 0 | 1 (16.7) 1 | 0 | 1 (11.1) 2 | 4 (66.7) 4 | 0 | 0 |
| Agitation | 0 | 0 | 0 | 0 | 2 (33.3) 3 | 2 (66.7) 3 | 0 |
| Muscle twitching | 0 | 0 | 0 | 3 (33.3) 4 | 0 | 0 | 0 |
| Diarrhea | 0 | 0 | 1 (16.7) 1 | 0 | 2 (33.3) 2 | 0 | 0 |
| Hyperhidrosis | 0 | 0 | 1 (16.7) 1 | 0 | 1 (16.7) 1 | 1 (33.3) 1 | 0 |
| Abdominal pain | 0 | 0 | 0 | 2 (22.2) 2 | 0 | 0 | 0 |
| Vomiting | 1 (16.7) 1 | 0 | 0 | 0 | 0 | 1 (33.3) 1 | 0 |
| Fatigue | 0 | 0 | 0 | 2 (22.2) 2 | 0 | 0 | 0 |
| Thirst | 0 | 0 | 0 | 0 | 2 (33.3) 2 | 0 | 0 |
| Tremor | 0 | 0 | 0 | 1 (11.1) 1 | 0 | 1 (33.3) 1 | 0 |
| Feeling hot | 0 | 0 | 1 (16.7) 1 | 0 | 0 | 0 | 1 (8.3) 1 |
| Myalgia | 0 | 0 | 0 | 0 | 1 (16.7) 2 | 0 | 0 |
| Dysphoria | 0 | 0 | 0 | 0 | 1 (16.7) 2 | 0 | 0 |
| Gastroenteritis | 0 | 0 | 0 | 0 | 0 | 0 | 1 (8.3) 1 |
| Chest discomfort | 0 | 1 (16.7) 1 | 0 | 0 | 0 | 0 | 0 |
| Injection site bruising | 0 | 0 | 0 | 1 (11.1) 1 | 0 | 0 | 0 |
| Folliculitis | 1 (16.7) 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Musculoskeletal injury | 0 | 0 | 0 | 1 (11.1) 1 | 0 | 0 | 1 (8.3) 2 |
| Palpitations | 0 | 0 | 1 (16.7) 1 | 0 | 0 | 0 | 1 (8.3) 1 |
| Ageusia | 0 | 0 | 0 | 0 | 1 (16.7) 1 | 0 | 0 |
| Syncope | 0 | 0 | 0 | 1 (11.1) 1 | 0 | 0 | 0 |
| Tension headache | 0 | 0 | 0 | 1 (11.1) 1 | 0 | 0 | 0 |
| Anxiety | 0 | 0 | 1 (16.7) 1 | 0 | 0 | 0 | 0 |
| Fear | 0 | 0 | 0 | 0 | 0 | 1 (33.3) 1 | 0 |
| Hallucination | 0 | 0 | 0 | 0 | 1 (16.7) 1 | 0 | 0 |
| Irritability | 0 | 0 | 0 | 0 | 0 | 1 (33.3) 1 | 0 |
| Hypotension | 0 | 0 | 0 | 0 | 1 (16.7) 1 | 0 | 0 |